FDA.reportPublic FDA data

Methylten 25%

Manufacturer
PureTek Corporation
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:02

Label at a glance#

ProductMethylten 25% Pain Relieving
Active ingredientMETHYL SALICYLATE
Label structure8 sections

Indications and uses

■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and administration

■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician.

Storage and handling

■ Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl salicylate 25%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

WARNINGS SECTION

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all other drugs out of the reach of children.

When using this product

OTC - WHEN USING SECTION

■ Avoid contact with eyes ■ Do not bandage tightly ■ Do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - DO NOT USE SECTION

■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician.

Other information

STORAGE AND HANDLING SECTION

■ Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Borago Officinalis (Borage) Seed Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-Alpha Tocopheryl Acetate, Eucalyptus Globus Leaf Oil, Fructose, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil, Fragrance.

Methylten™ 25%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free: 1 -877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238542methyl salicylate 25 % Topical CreamPSN1
238542methyl salicylate 250 MG/ML Topical CreamSCD1
238542methyl salicylate 25 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-245-06Methylten 25%Pain Relieving60 g in 1 JARCREAM601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-245-06GM - Gram59088-245e287affc-2a82-4eb0-8bad-a84c86da6ae112025-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-24559088-245-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
EUCALYPTUS OIL2R04ONI662IACT
WATER059QF0KO0RIACT
METHYL SALICYLATELAV5U5022YACTIB
ALOE VERA LEAFZY81Z83H0XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM HYDROXIDE55X04QC32IIACT
SQUALANEGW89575KF9IACT
BORAGE SEED OILF8XAG1755SIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
FRUCTOSE6YSS42VSEVIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT
GRAPE SEED OIL930MLC8XGGIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylten 25% Pain RelievingMETHYL SALICYLATEPureTek Corporation3767b97e-ab0c-ac26-e063-6394a90a00cf2025-06-12WarningsExact identifier
ndc (package): 59088-245-06
ndc (product): 59088-245
ndc11 (package): 59088024506
spl id: 3767b97e-ab0c-ac26-e063-6394a90a00cf
spl set id: 3767b97e-ab0c-ac26-e063-6394a90a00cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.